Methylphenidate Extended-release

— THERAPEUTIC CATEGORIES —
  • ADHD
  • Sleep-wake disorders

Methylphenidate Extended-release Generic Name & Formulations

General Description

Methylphenidate HCl 10mg, 20mg; ext-rel tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Tabs, ext-rel tabs, chew tabs—contact supplier; Oral soln—500mL

Mechanism of Action

The mechanism of action of methylphenidate is not completely understood, but it presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Methylphenidate Extended-release Indications

Indications

Attention deficit hyperactivity disorder.

Methylphenidate Extended-release Dosage and Administration

Adults and Children

Swallow whole. May use methylphenidate extended-release tabs in place of methylphenidate tabs when the 8-hr dose of methylphenidate extended-release corresponds to the titrated 8-hr dose of methylphenidate. Max 60mg daily.

Methylphenidate Extended-release Contraindications

Contraindications

During or within 14 days of MAOIs. 

Methylphenidate Extended-release Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Methylphenidate Extended-release Warnings/Precautions

Warnings/Precautions

High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Seizure disorder. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Risk for acute angle closure glaucoma. History of increased IOP or open angle glaucoma; monitor closely. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Monitor BP, HR, growth in children. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

Methylphenidate Extended-release Pharmacokinetics

Elimination

Renal.

Methylphenidate Extended-release Interactions

Interactions

See Contraindications. Avoid alcohol. Hypertensive crisis with MAOIs. Caution with pressor agents. Antagonizes guanethidine. May potentiate coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, tricyclics, SSRIs. May antagonize antihypertensive drugs; monitor and adjust dose of antihypertensives as needed. Concomitant halogenated anesthetics may increase the risk of sudden BP and HR increase during surgery; avoid use. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

Methylphenidate Extended-release Adverse Reactions

Adverse Reactions

Insomnia, nervousness, CNS overstimulation, anorexia, weight loss, abdominal pain, nausea, dizziness, headache; priapism, hypertension, tachycardia, visual disturbances, glaucoma, motor/verbal tics.

Methylphenidate Extended-release Clinical Trials

See Literature

Methylphenidate Extended-release Note

Not Applicable

Methylphenidate Extended-release Patient Counseling

See Literature

Methylphenidate Extended-release Generic Name & Formulations

General Description

Methylphenidate HCl 10mg, 20mg; ext-rel tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Tabs, ext-rel tabs, chew tabs—contact supplier; Oral soln—500mL

Mechanism of Action

The mechanism of action of methylphenidate is not completely understood, but it presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Methylphenidate Extended-release Indications

Indications

Narcolepsy.

Methylphenidate Extended-release Dosage and Administration

Adults and Children

Swallow whole. May use methylphenidate extended-release tabs in place of methylphenidate tabs when the 8-hr dose of methylphenidate extended-release corresponds to the titrated 8-hr dose of methylphenidate. Max 60mg daily.

Methylphenidate Extended-release Contraindications

Contraindications

During or within 14 days of MAOIs. 

Methylphenidate Extended-release Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Methylphenidate Extended-release Warnings/Precautions

Warnings/Precautions

High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Seizure disorder. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Risk for acute angle closure glaucoma. History of increased IOP or open angle glaucoma; monitor closely. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Monitor BP, HR, growth in children. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

Methylphenidate Extended-release Pharmacokinetics

Elimination

Renal.

Methylphenidate Extended-release Interactions

Interactions

See Contraindications. Avoid alcohol. Hypertensive crisis with MAOIs. Caution with pressor agents. Antagonizes guanethidine. May potentiate coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, tricyclics, SSRIs. May antagonize antihypertensive drugs; monitor and adjust dose of antihypertensives as needed. Concomitant halogenated anesthetics may increase the risk of sudden BP and HR increase during surgery; avoid use. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

Methylphenidate Extended-release Adverse Reactions

Adverse Reactions

Insomnia, nervousness, CNS overstimulation, anorexia, weight loss, abdominal pain, nausea, dizziness, headache; priapism, hypertension, tachycardia, visual disturbances, glaucoma, motor/verbal tics.

Methylphenidate Extended-release Clinical Trials

See Literature

Methylphenidate Extended-release Note

Not Applicable

Methylphenidate Extended-release Patient Counseling

See Literature